ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01534819

Collaborator

(none)

1,090

Enrollment

Locations

152.1

Anticipated Duration (Months)

12.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.

Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm	Device: EndoAnchor™ Procedure: endovascular treament

Detailed Description

The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-FX™ EndoAnchor™ System. This registry will include "real world" use over a broad spectrum of geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection criteria.

Study Design

Study Type:

Observational

Actual Enrollment :

1090 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Dec 3, 2020

Anticipated Study Completion Date :

Dec 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Protocol B, abdominal arm, revision group AAA subjects with previously implanted commercial endografts for the treatment of graft migration and/or Type Ia endoleak	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol B, abdominal arm, primary group AAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol B, thoracic arm, revision group TAA subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol B, thoracic arm, primary group TAA subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol B, advanced disease arm, revision group Advanced disease subjects with previously implanted commercial endografts for the treatment of migration and/or Type Ia and/or Type Ib endoleak at the proximal or distal attachment site	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol B, advanced disease arm, primary group Advanced disease subjects at the time of initial endograft implantation either to prevent endograft migration and Type I endoleak, or to treat Type Ia and/or Ib endoleak at the proximal or distal attachment site evident at the time of implantation.	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery
Protocol C, abdominal arm, short neck, primary group Planned use of Heli-FX™ in conjunction with the Endurant II/IIs endograft in AAA subjects with short proximal necks (≥ 4 mm and < 10 mm) in primary group.	Device: EndoAnchor™ Use of the EndoAnchor™ in conjunction with endograft Other Names: Heli-FX™ Heli-FX™ EndoAnchor™ System Procedure: endovascular treament implantation of a device inserted through an artery

Outcome Measures

Primary Outcome Measures

Protocol B has composite primary safety endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms [Through 12 months]
The primary safety endpoint is defined by: i. freedom from device-related serious adverse events at 12 months and ii. freedom from procedure-related serious adverse events at 12 months iii. freedom from aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Protocol B has composite primary effectiveness endpoints, tabulated separately for the abdominal, thoracic and advanced disease arms [Through 12 months]
The primary effectiveness endpoint requires all of the following: i successful implantation of the minimum number of EndoAnchor™ and ii freedom from migration at 12 months and iii freedom from Type I endoleak at the targeted attachment site(s) at 12 months
Protocol C has composite primary safety endpoint [Through 12 months]
The primary safety endpoint is defined by: device-related serious adverse events at 12 months aneurysm-related mortality defined as: i. death within 30 days of the index procedure ii. death within 30 days of a secondary procedure to address the aneurysm iii. death from rupture of the treated aneurysm
Protocol C have composite primary effectiveness endpoint [Through 12 months]
The primary effectiveness endpoint is treatment success which is defined as the successful implantation of EndoAnchor™ implants at the index procedure, and the absence of: migration at 12 months and Type I endoleak at the targeted attachment site(s) at 12 months

Secondary Outcome Measures

Protocol B has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter. [Through 5 years]
Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally Clinical success will be defined as the successful implantation of the suggested number of EndoAnchor™ at the index procedure, and the absence of: death as a result of aneurysm-related treatment; Type Ia endoleak; Type Ib endoleak (TAA and advanced disease only); endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair Secondary aneurysm-related interventions after EndoAnchor™ implantation all-cause mortality Freedom from EndoAnchor™ fracture
Protocol C has the secondary endpoints chosen to reflect the clinical success and safety of Heli-FX™. Each of the secondary endpoints will be measured individually at 30 days and 12 months and yearly thereafter. [Through 5 years]
Technical success defined as successful deployment of EndoAnchor™ at their intended location. Technical success will be assessed separately for the target attachment sites; proximally and/or distally Clinical success will be defined as the successful implantation of EndoAnchor™ at the index procedure, and the absence of: aneurysm-related mortality; Type Ia endoleak; endograft infection; endograft migration; loss of endograft fabric integrity as a result of the EndoAnchor™; Rupture of the treated aneurysm; Conversion to open surgical repair Secondary aneurysm-related interventions after EndoAnchor™ implantation all-cause mortality EndoAnchor™ implant fracture

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Protocol B:

Inclusion criteria:

Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
Subject ≥ 18 years old
Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
Subject is willing and able to comply with standard of care followup evaluations
Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:

Cook Zenith or Cook Zenith TX2
Gore Excluder or TAG
Medtronic AneuRx
Medtronic Talent
Medtronic Endurant or Valiant
Any additional third party AAA endograft device that is commercially available and listed as compatible with Heli-FX™ in the IFU

Subject's iliac/femoral access is compatible with:

a 16 French sheath (abdominal subjects)
18 French sheath (thoracic subjects)
Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)

Subject has a previously implanted endograft that has migrated or has a Type I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications

Exclusion criteria:

Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
Subject has a life expectancy of less than 1 year
Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
Subject was treated with EndoAnchor™ in the same segment of the aorta that will be treated in the registry
Subject has an active or known history of bleeding diathesis
Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
Significant thrombus or calcium at the location of planned EndoAnchor™ implantation that precludes adequate EndoAnchor™ penetration of the aortic wall
Use where, for whatever reason, each EndoAnchor™ is not anticipated to adequately penetrate into the aortic wall
Subject has an aortic dissection that involves an area to be treated with EndoAnchor™
Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
Subject is pregnant

Protocol C:

Inclusion criteria:

Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
Subject ≥ 18 years old
Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
Subject is willing and able to comply with standard of care followup evaluations
Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to < 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
Subject's iliac/femoral access is compatible with a 16 French sheath

Exclusion criteria:

Subject has known allergy to the EndoAnchor™ implant material (nickel, chromium, molybdenum, or cobalt)
Subject has a life expectancy of less than 1 year
Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
Subject was previously treated with EndoAnchor™ implants in the same segment of the aorta that will be treated within the registry, or has a previously implanted AAA endograft that has migrated or has a Type Ia endoleak, or is being treated for a ruptured abdominal aortic aneurysm, or has planned usage of an Endurant II/IIs AUI main body stent graft configuration
Subject has an active or known history of bleeding diathesis
Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
Significant thrombus or calcium at the location of planned EndoAnchor™ device implantation that precludes adequate EndoAnchor™ implant penetration of the aortic wall
Use where, for whatever reason, each EndoAnchor™ implant is not anticipated to adequately penetrate into the aortic wall
Subject has an aortic dissection that involves an area to be treated with EndoAnchor™ implants
Subject has Marfan Syndrome, Ehlers Danlos Syndrome, or another collagen vascular disease
Subject is pregnant
Physician does not intend to treat subject on-label per the Endurant II/IIs and Heli-FX™ IFU requirements or if the physician intends to use Heli-FX™ in a chimney procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Abrazo Arizona Heart Institute	Phoenix	Arizona	United States	84006
3	John L McClellan Memorial Veterans Hospital	Little Rock	Arkansas	United States	72205
4	VA Loma Linda Medical Center	Loma Linda	California	United States	92357
5	El Camino Hospital	Mountain View	California	United States	94040
6	University of California Irvine Medical Center	Torrance	California	United States	90502-2004
7	Harbor - UCLA Medical Center	Torrance	California	United States	90509
8	Yale University School of Medicine	New Haven	Connecticut	United States	06510
9	MedStar Georgetown University Hospital Vascular Surgery Dept.	Washington	District of Columbia	United States	20007
10	Baptist Cardiac & Vascular Institute	Miami	Florida	United States	33176
11	Florida Hospital	Orlando	Florida	United States	32751
12	University of South Florida	Tampa	Florida	United States	33606
13	Emory University Hospital	Atlanta	Georgia	United States	30322-1059
14	Kaiser Permanente Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
15	HeartCare Midwest	Peoria	Illinois	United States	61614
16	Evanston Hospital	Skokie	Illinois	United States	60077
17	Southern Illinois University	Springfield	Illinois	United States	62702
18	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
19	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21401
20	Beth Israel Deaconess-Harvard	Boston	Massachusetts	United States	02215
21	Michigan Vascular Center	Flint	Michigan	United States	98507
22	William Beaumont Hospital	Royal Oak	Michigan	United States	48703
23	Washington University School of Medicine, Barnes Jewish West County Hospital	Saint Louis	Missouri	United States	63110
24	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
25	Albany Medical Center	Albany	New York	United States	12208
26	Montefiore Medical Center	Bronx	New York	United States	10467
27	New York University Langone Medical Center	New York	New York	United States	10016
28	The Mount Sinai Hospital	New York	New York	United States	10029
29	Maimonides Medical Center	New York	New York	United States	11219
30	Vascular Health Partners	Queensbury	New York	United States	12804
31	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
32	Mission Hospital	Asheville	North Carolina	United States	28806
33	University of North Carolina (UNC) Memorial Hospital	Chapel Hill	North Carolina	United States	27599
34	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
35	Duke University Medical Center	Durham	North Carolina	United States	27710
36	Cleveland Clinic	Cleveland	Ohio	United States	44195
37	UPMC Pinnacle Harrisburg Campus	Wormleysburg	Pennsylvania	United States	17043
38	Medical University of South Carolina (MUSC)	Charleston	South Carolina	United States	29425
39	Lexington Medical Center	West Columbia	South Carolina	United States	29169
40	CHI Memorial Hospital Chattanooga	Chattanooga	Tennessee	United States	37403
41	Baptist Memorial Hospital-Memphis	Memphis	Tennessee	United States	38120
42	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
43	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
44	Scott and White Medical Center	Temple	Texas	United States	76508
45	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
46	Harborview Medical Center, University of Washington	Seattle	Washington	United States	98104
47	Concord Repatriation General Hospital	Concord		Australia	NSW 2139
48	Dandenong Hospital	Dandenong		Australia	VIC 3175
49	Royal Perth Hospital	Perth		Australia	WA 6000
50	Sir Charles Gairdner Hospital	Perth		Australia
51	Royal North Shore Hospital	St. Leonards		Australia	NSW 2065
52	A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck	Innsbruck		Austria
53	Allgemeines Krankenhaus - Universitätskliniken Wien	Wien		Austria
54	Hôpital Pontchaillou	Rennes		France
55	Nouvel Hôpital Civil	Strasbourg		France
56	Medizinische Fakultät der RWTH	Aachen		Germany
57	Deutsches Herzzentrum	Berlin		Germany
58	University Hospital Heidelberg	Heidelberg		Germany
59	Park Hospital Leipzig	Leipzig		Germany
60	St. Bonifatius Hospital	Lingen		Germany
61	Klinikum Ludwigsburg	Ludwigsburg		Germany
62	LMU Kilinikum der Universitaet Muenchen	Munich		Germany
63	Technical University of Munich	Munich		Germany
64	St. Franzsikus-Hospital GmbH	Munster		Germany
65	Klinikum Nuremberg	Nuremberg		Germany
66	Azienda Ospedaliero-Universitaria Careggi	Florence		Italy
67	AO Universitaria Policlinico	Roma		Italy
68	Unihospital San Giovanni di Dio Ruggi d'Aragona	Salerno		Italy	84131
69	University of Siena	Siena		Italy
70	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino		Italy
71	Rijnstate Hospital	Arnhem		Netherlands
72	Medisch Spectrum Twente	Enschede		Netherlands
73	St. Antonius Hospital	Nieuwegein		Netherlands
74	Maasstad Hospital Rotterdam	Rotterdam		Netherlands
75	UMC Utrecht	Utrecht		Netherlands
76	Auckland City Hospital	Auckland		New Zealand	1023
77	Auckland City Hospital	Auckland		New Zealand
78	Narodny ustav srdcovych a cievnych chorob	Nové Mesto		Slovakia
79	Thorax Institute Hospital Clinic	Barcelona		Spain
80	Hospital Universitario Donostia	Donostia / San Sebastián		Spain
81	Hospital Clínico Universitario de Valladolid	Valladolid		Spain
82	Malmo University Hospital	Malmo		Sweden
83	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland
84	UniversitätsSpital Zürich	Zürich		Switzerland
85	The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital	Liverpool		United Kingdom
86	Imperial College Healthcare NHS Trust	London		United Kingdom
87	Wythenshawe Hospital	Manchester		United Kingdom
88	The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital	Newcastle upon Tyne		United Kingdom

Sponsors and Collaborators

Medtronic Cardiovascular

Investigators

Principal Investigator: Jean-Paul de Vries, MD, Universitair Medisch Centrum Groningen, Netherlands
Principal Investigator: William Jordan, MD, Emory University, United States